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Pharmacopsychiatry 2009; 42(4): 145-152
DOI: 10.1055/s-0028-1128115
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Translation of Randomised Controlled Trial Findings into Clinical Practice: Comparison of Olanzapine and Valproate in the EMBLEM Study

D. Novick 1 , A. Gonzalez-Pinto 2 , J. M. Haro 3 , J. Bertsch 3 , C. Reed 1 , E. Perrin 4 , M. Tohen 5 , and The EMBLEM Advisory Board
  • 1Eli Lilly and Company, Lilly Research Centre, Erl Wood Manor, Windlesham, Surrey, UK
  • 2Santiago Aposol Hospital, Vitoria, Spain
  • 3Sant Joan de Deu-SSM, Fundacio Sant Joan de Deu, Sant Boi de Llobregat, Barcelona, Spain
  • 4Eli Lilly and Company, Paris, France
  • 5Lilly Research Laboratories, Indianapolis IN, USA
Weitere Informationen

Publikationsverlauf

received 01.07.2008 revised 04.12.2008

accepted 04.12.2008

Publikationsdatum:
07. Juli 2009 (online)

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Abstract

Objectives: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments.

Methods: EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively.

Results: 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate.

Discussion: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.

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Correspondence

D. Novick

Eli Lilly and Company

Lilly Research Centre

Erl Wood Manor

Sunninghill Road

Windlesham

Surrey GU20 6PH

UK

Telefon: +44/1276/48 38 32

Fax: +44/1276/48 31 92

eMail: Novick_diego@lilly.com